Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER

K-Number: K896334 · 1989-12-11

ApplicantCreative Laboratory Products, Inc.
Decision Date1989-12-11
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER is the device name listed in this FDA 510(k) record. The listed applicant is Creative Laboratory Products, Inc.. It received FDA 510(k) clearance on 1989-12-11 under 510(k) number K896334. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER?

CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER is a medical device that received FDA 510(k) clearance on 1989-12-11. The listed applicant is Creative Laboratory Products, Inc.. The 510(k) number is K896334.

When did CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER receive FDA 510(k) clearance?

CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER received FDA 510(k) clearance on 1989-12-11, under 510(k) number K896334.

Who is the listed applicant for CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER?

The FDA 510(k) record lists Creative Laboratory Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER?

The FDA product code for CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER is LCP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Creative Laboratory Products, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K950589CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HLK942284CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SETK922995LIPID CONTROLSK913427SICKLE HEMOGLOBIN (HBA/S) CONTROL SETK913371TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CALK913585LIPASE LINEARITY CONTROL

View all 27 devices →

Related Devices (Code: LCP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical CorporationK231465Q-Pad Test SystemQurasenseK214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies ASK192987Aina HbA1c Monitoring System 2Jana Care, Inc.K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd.K183230OneDraw A1C Test SystemDrawbridge Health, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑